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Silicone Round Drain Kit

by Fortune Medical Instrument Corp. 10 variants

Ref CO2015-9218

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04711182605735 Basic UDI-DI Date18 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
CO2015-9218
Primary DI / UDI-DI
04711182605735, 14711182605732
Basic UDI-DI
B-04711182605735, B-14711182605732
EMDN Code
A0601010402 Cylindrical or circular drainages (straight and t-shaped)
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000009221
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Biliary drain

Other devices from Fortune Medical Instrument Corp.

See all devices from Fortune Medical Instrument Corp. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No